Narrow Band Imaging Project on Barrett's Esophagus

NCT ID: NCT01580631

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2025-12-31

Brief Summary

Narrow Band Imaging(NBI) improves image contrast by allowing the blue light centered at 415 nanometers which is heavily absorbed by oxyhemoglobin to highlight the tissue's microvasculature and enhances detail on the surface of the mucosa revealing subtle changes. Barrett's esophagus(BE) has the mucosal and vessel changes during cancer transformation by angiogenesis. The ability of the NBI scope to visualize submucosal vessels forms the premise for the prediction of dysplasia in BE mucosa.

NBI images of the BE mucosa obtained during endoscopy will be classified by academic endoscopists and community endoscopists initially. The endoscopists will then be asked to predict histopathology based on the NBI surface patterns. This clinical trial will evaluate the inter-observer agreement of a simple, consensus driven narrow band imaging (NBI) classification system of surface patterns and its ability to differentiate dysplastic versus non-dysplastic Barrett's esophagus(BE) in patients undergoing BE screening or surveillance in expert academic centers and in community GI practice as well. Their performance will be evaluated for accuracy, sensitivity, specificity, positive predictive value and negative predictive value of each pattern that is visualized on NBI.

Detailed Description

This is a multicenter, prospective, double-blinded study of NBI images from 50 patients enrolled in the study. Patients undergoing BE screening and BE surveillance will be enrolled into the study. After meeting eligibility criteria, and obtaining an informed consent, patients will undergo their routine upper endoscopic examination using white light endoscopy. During the course of the upper endoscopy, the BE surface patterns will be carefully examined with the endoscope in overview mode (with the endoscope in the center of the esophageal lumen) and then in close proximity to the BE surface (approximately 3-5 mm away from the mucosa). In each of these positions, a maximum of 4 high quality images will be obtained from different surface patterns initially with WLE and then using NBI. Image capture will be standardized. All the images will be classified based upon a simplified NBI classification system using two main criteria:(1)mucosal pattern(regular/irregular/uncertain) and (2)vascular pattern (regular/irregular/uncertain). All images will be captured using a high-definition, NBI endoscope (190 endoscopes-GIF-HQ 190 [dual focus],Olympus Inc) and stored in the high quality TIFF format. After images have been obtained, target biopsies will be obtained from each area and submitted for histopathological evaluation in separate jars. From the reports on NBI patterns from the images by Gastroenterologist and corresponding histopathological details, the accuracy and interobserver agreement of this NBI classification system will be determined.

Conditions

Barrett's Esophagus; Gastroesophageal Reflux Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

BE with dysplasia.

Patients having Barrett's esophagus with dysplasia.

No interventions assigned to this group

BE without dysplasia.

Patients having Barrett's esophagus without dysplasia.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients age: ≥ 18 years
• Undergoing endoscopy for surveillance or endoscopic treatment of Barrett's esophagus
• Ability to take oral proton pump inhibitor
• For female subjects of childbearing potential, a negative urine pregnancy test within 2 weeks of enrollment and any subsequent endoscopy encounter
• Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the investigational plan
• Ability to discontinue Aspirin/NSAIDs/Clopidogrel 7 days before and after all ablation procedures
• Ability to provide written, informed consent and understands the responsibilities of trial participation

Exclusion Criteria

• The subject is pregnant or planning a pregnancy during the study period (12 months after treatment)
• Esophageal stricture preventing passage of endoscope or catheter
• Active erosive esophagitis
• Prior endoscopic therapy with endoscopic mucosal resection, radiofrequency ablation, etc.
• History of esophageal varices or coagulopathy
• Prior radiation therapy to the esophagus, except head and neck region radiation therapy.
• Evidence of esophageal varices during treatment endoscopy
• Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
• The subject is currently enrolled in an investigational drug or device trial that clinically interferes with the current study.
• Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kansas City Veteran Affairs Medical Center

FED

Sponsor Role: collaborator

Midwest Biomedical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

PRATEEK SHARMA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prateek Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

Kansas City VA Medical Center

Irving Waxman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Jacques Bergman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Helmut Messman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg

Kenichi Goda, MD

Role: PRINCIPAL_INVESTIGATOR

Jikei University

Motosugu Kato, MD

Role: PRINCIPAL_INVESTIGATOR

Hokkaido University

Locations

The University of Chicago Medical Center

Chicago, Illinois, United States

Kansas City VA Medical Center

Kansas City, Missouri, United States

University of Regensburg

Augsburg, , Germany

Amsterdam Medical Center

Amsterdam, , Netherlands

Countries

United States; Germany; Netherlands

References

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Reference Type: BACKGROUND

PMID: 8514029 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

PS0059

Identifier Type: -

Identifier Source: org_study_id